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Volume 23 Number 12 December 2014/January 2015

ALSO IN THIS ISSUE:

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■ Key Benefits of Investigator Portals

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Corporate Profilesbegin on page 26

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appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 3December 2014/January 2015

CONTENTSA P P L I E D C L I N I C A L T R I A L S

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Townsend N. Barnett, Jr.Vice President, Global Head of Pre-Clinical and Clinical QAUCB Pharma S.A.Chemin du Foriest, Belgium

Maarten Beekman, MDVice President, Medical & Regulatory AffairsAstraZeneca Zoetermeer, Netherlands

Timothy Callahan, PhDChief Scientific OfficerBiomedical SystemsSaint Louis, MO

Jo Collier, MBChB, FFPMVP Experimental MedicineMedical DepartmentQuotient ClinicalNottingham, UK

Anthony J. CostelloChief Executive OfficerMytrus, Inc.San Francisco, CA

Domenico Criscuolo, MD, PhD, FFPMChief Executive OfficerGenovaxColleretto Giacosa, Italy

Srini Dagalur, PhDSpecialist Leader, Life Sciences Technology StrategyDeloitteParsippany, NJ

Edward Stewart Geary, MDChief Medical Officer & Vice PresidentEisai Co., Ltd.Tokyo, Japan

Jan GeisslerDirector, European Patients’ Academy on Therapeutic Innovation (EUPATI)Riemerling, Germany

Ashok K. Ghone, PhDVP, Global ServicesMakroCare1 Washington Park, Suite 1303Newark, NJ 07102

Rahlyn GossenFounderRebar Interactive New Orleans, LA

Uwe Gudat, MDHead of Safety, BiosimilarsMerck SeronoGeneva, Switzerland

Ira M. KatzConsultantInsigniamNarberth, PA

Darshan Kulkarni , PharmD, EsqPrincipal AttorneyThe Kulkarni Law FirmPhiladelphia, PA

Michael R. Hamrell, PhD, RACPresidentMORIAH ConsultantsHuntington Beach, CA

Erica J. Heath, CIP, MBAPresidentEthical and Independent Review Services, LLCSan Anselmo, CA

Patricia E. Koziol, PhDPresidentPEK Associates, Inc.Holmdel, NJ

Jeffrey S. Litwin, MDChief Scientific and Strategic ConsultantERTPhiladelphia, PA

VIcky Parikh, MD, MPHExecutive DirectorMid-Atlantic Medical Research CentersHollywood, MD

Timothy Pratt, PhD, MBASenior Principal Medical Research ManagerNAMSAMinneapolis, MN

Stephen Senn, PhDHead of Competence Center for Methodology and StatisticsCRP-SanteStrassen, Luxembourg

Johanna Schenk, MD, FFPMManaging Director and Chief Operating OfficerPPH PlusFrankfurt, Germany

Albert J. Siemens, PhDChairman and CEOFHI 360Research Triangle Park, NC

Philippa Smit-Marshall,

MB ChB, BSc, FFPM, FICRVice President and General Manager Pediatrics and Medical SciencePharmaNet/i3Leusden, The Netherlands

Thomas Sudhop, MDDirector and ProfessorFederal Institute for Drugsand Medical DevicesBonn, Germany

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4 APPLIED CLINICAL TRIALS appliedclinicaltrialsonline.com December 2014/January 2015

CONTENTS

O U R M I S S I O N

Applied Clinical Trials is the authoritative, peer-reviewed resource and thought leader for the global community that designs,

initiates, manages, conducts, and monitors clinical trials. Industry professionals learn effective and efficient solutions

to strategic and tactical challenges within the tightly regulated, highly competitive pharma ceutical environment.

A P P L I E D C L I N I C A L T R I A L SVOLUME 23, NUMBER 12

COMMENTARY

VIEW FROM BRUSSELS

10 Health Challenges Mount for Europe

Peter O’Donnell

CLINICAL TRIAL INSIGHTS

12 Education and Satisfaction Disparities Among European Patients

Kenneth A. Getz

A CLOSING THOUGHT

42 Clinical Document Exchange Portals: Trendy or Revolutionary?

Kevin Wojcikewych

CLINICAL TRIALS COMMUNITY

6 APPLIED CLINICAL TRIALS ONLINE

8 NEWS

CORPORATE PROFILES

26 CORPORATE PROFILES

MARKETPLACE

40 CLASSIFIED

CLINICAL TECHNOLOGY

20 How Mobile Technology is Evolving in Clinical Trials

Tim Davis

Analyzing the emergence of mobile

customization in meeting the

specific requirements of studies.

CLINICAL TECHNOLOGY

23 Steps for a Successful Clinical Trial Management System

Erika Stevens, Christina

Eberthart, Jim Moran

Academic health centers are assessing

options to better control the flow

of data and boost compliance.

COVER STORY

14 The Future of ePRO PlatformsAlan Yeomans

The practicality and benefits of using a subject’s own

mobile device to collect patient-reported outcomes. FU

SE/G

ETTYIM

AG

ES

ES542852_ACT1214_004.pgs 12.10.2014 21:35 ADV blackyellowmagentacyan

Today, trial decisions must be made more quickly and efficiently than

ever before. Success demands a new kind of CRO partner — one

with strategic and flexible solutions that assure the fastest possible

route to quality clinical results.

At inVentiv Health Clinical, we are that next-generation CRO. A top

provider of Phase I-IV global drug development services, we take a

patient-centric approach and apply smarter, fresher thinking to go

well beyond traditional outsourced services.

And, as part of inVentiv Health, we leverage the expertise and

resources of a much larger organization to apply real-world

commercial and consulting insights for clients in over 70 countries.

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ES542718_ACT1214_005_FP.pgs 12.10.2014 21:03 ADV blackyellowmagentacyan


WEB CONTENTS

appliedclinicaltrialsonline.comwww.linkedin.com/groups/Applied-Clinical-Trials-2949042/about

twitter.com/clin_trials

Why do we audit our suppliers and what

do we hope to achieve when we do? Cer-

tainly, regulated companies need to ensure

their systems meet both business and regu-

latory requirements, which include systems

provided by third-party suppliers.

To meet the rapidly evolving needs of reg-

ulated companies, many technology suppli-

ers have adopted advanced development,

implementation, and hosting methods. All

too often, however, unprecedented and unfa-

miliar methodologies leave these same regu-

lated companies unsure of how to audit in a

way that is sufficient for purpose and compli-

ant with regulatory expectations and their

own procedures. Thus, audit practices need

a facelift to keep pace with the technologies

that need to be assessed.

In mid-2012, the U.S. Government Account-

ing Office identified a number of practices

and approaches as effective for applying Agile

software development methods to IT projects.

More recently, in mid-2013, the U.S. Federal

Risk and Authorization Management Program

approved a cloud technology provider for use

in government business. Although these no-

tices are specific to the U.S., it is not a great

leap to envision other government entities

within the U.S., as well as healthcare regula-

tors worldwide, recognizing the value and

necessity of considering new technologies as

they look to improve their own operations.

N O T E W O R T H Y

Go to:

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.com to read these

exclusive stories and

other featured content.

Social Media Have you joined our

LinkedIn group or follow

us on Twitter? Here’s our

most popular content on

LinkedIn if you missed it:

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Technologies

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2. Sponsor-Investigator

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Research

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BlogsOur top 3 most-read blogs

last month:

1. Why Pfizer is Hungry for

Acquisition

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eNewslettersNext year starts our

regular enews cover-

age. January features:

ACT Direct, 1/6; 1/13;

1/20 and 1/27. Oncology,

1/8; RBM, 1/14; Patient

Engagement, 1/22 and

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Value-Based Auditing of Software Suppliers

Visit bit.ly/1tYvrvB for the full version of this article

Applied Clinical Trials Online New

Look Revealed!Our efforts to improve our website function and

design have arrived. We continue to categorize

information to our zones: CRO/Sponsor, Sites,

ClinTech, Labs, Regulatory, and Trial Design,

but we have also added a section for Project

Managers, and links to hot or trending topics,

currently Risk-Based Monitoring and Clinical

Trials Data Sharing. Go online and learn more

about the many resources we offer. www.

appliedclinicaltrialsonline.com

eLearning

Characteristics

of Successful

Project Managers.

Long-term experience in clinical research 9%4% 7%13%3%

2%4%

7%2%

3%

6%

15%8%3%10% 38%

44%

26%

23%15%6%

10% 20% 30% 40% 50%

34%

3%0%

3%

Risk awareness

Medical expertise

Knowledge of drug development

Innovative

Confdence-building

Dependability

Efective communication

Clear goals

Proactive working style

Rated as ‘3’

Rated as ‘2’

Rated as ‘1’

Source: Yakov Datsenko and

Johanna Schenk, PPH plus


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NEWS

V I E W F R O M W A S H I N G T O N

Virtually all new injectible drugs and bi-

ologics are being developed as combi-

nation therapies, with special delivery

systems designed to ensure proper dos-

ing. An FDA rule issued in January 2013 on

manufacturing standards for drug-device

combination products indicates that its

requirements apply to a wide spectrum

of therapies utilizing syringes, patches,

pumps, inhalers, nasal vaccines, targeted

nanoparticles, and other delivery systems.

The promise is that customized deliv-

ery of injectible drugs and biologics will

reduce toxicity, enhance individual re-

sponse, facilitate the delivery of multiple

drugs, minimize waste, and encourage pa-

tient adherence to prescribed treatment.

These features are particularly important

for personalized therapies that tend to

target small patient populations and seek

to justify higher prices based on enhanced

value.

Biopharmaceutical companies, thus,

are “transitioning overnight” into combi-

nation product companies, commented

Dave Anderson, associate director for R&D

quality at MedImmune/AstraZeneca. This

involves developing therapies with de-

vices, packaging, and patient information

to meet the needs of prescribers and end

users, he explained at an October meeting

in Washington, D.C. on combination prod-

ucts sponsored by the Drug Information

Association (DIA). Anderson noted that

delivery of multiple sclerosis therapy has

evolved from using just pre-filled syringes

to sophisticated devices that can guide

the patient through the injection process

in 26 languages, adjust needle speed and

depth, and record time of use.

The development of such products of-

ten involves expanded preclinical testing

programs to include “human factor” test-

ing on whether patients can use a device

delivery system appropriately. Manufac-

turing controls and quality systems vary

considerably for drug and device compo-

nents, as does product labeling and post-

marketing requirements.

A first step in combination product

development is to determine whether it

should be regulated as a drug, biologic, or

device, based on primary mode of action.

For uncertain or complex situations, spon-

sors may consult FDA’s Office of Combina-

tion Products (OCP), which will decide if a

product is a combination and which FDA

center should oversee its development

program and market approval. OCP re-

ceived over 800 requests for consultations

in fiscal year 2013, and 330 combination

product submissions were filed during

that same period, with the drug the main

component in 153 cases. FDA Centers and

sponsors also sought assistance from

OCP in resolving nearly 400 regulatory

and development issues involving require-

ments for clinical and preclinical testing,

registration, and regulatory issues.

A range of industry collaborative mod-

els support combination product devel-

opment, explained Pfizer senior director

Kristen Paulsen at the DIA conference. She

noted that it is important to decide very

early in development what human factors

studies are needed to avoid problems in

Phase III trials, and to clarify responsibili-

ties for such issues as who is responsible

for shipping devices to sites and at what

study phase to test the drug and device in

combination. Sponsors need to file only

one application to begin clinical trials for

a combination product, noted OCP deputy

director Patricia Love. If the Center for

Drug Evaluation and Research (CDER) is

the lead, the program follows CDER poli-

cies and meeting process, with participa-

tion from OCP and other relevant Centers.

Regulatory confusion

FDA’s stated aim in issuing its January

2013 final rule on current good manufac-

turing practices (cGMPs) for combination

products is to encourage innovation by

streamlining the regulatory process for

ensuring compliance with manufacturing

standards. The rule seeks to avoid duplica-

tive requirements by establishing either

drug GMPs or device quality systems as

a foundation, and incorporating provi-

sions from other Centers as appropriate.

This approach applies to co-packaged and

single-entity combos, but not to vaccines,

cellular therapies, and other products reg-

ulated by the Center for Biologics Evalua-

tion and Research (CBER).

Yet FDA also indicates that design con-

trols for devices and release requirements

for drugs apply to the whole combination

product, which has generated confusion

over the “streamlining” process. An added

problem is how manufacturers should

deal with legacy combination products,

which often have gaps in now-required

development and production records. FDA

is receiving many questions on the GMP

rule and planned to address them in draft

guidance, promised for 2014. Industry con-

cerns have escalated since FDA issued a

warning letter to Amgen in January 2014

citing inadequate design validation, docu-

mentation of product changes, and con-

tractor controls for certain therapies the

agency defines as combination products.

At the same time, a revision of medical

device regulations by European regulatory

authorities is expected to impact develop-

ment and authorization of combination

products. Drugs and medical devices are

regulated very differently in the EU, which

lacks a specific program for overseeing

combination products, as in the U.S. The

development of more drugs with custom-

ized delivery systems, though, has brought

to the fore multiple “borderline issues”

involving EU oversight and authorization

of these products.

— Jill Wechsler

Sponsors Face New Challenges in Developing Combination Drugs


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NEWS

To see more View From Brussels articles, visit


Top of the news—even for a column

that appears with a schedule

only tenuously related to a news

agenda—has to be the untimely

and unfortunate removal of Guido Rasi

from his post as executive director of the

European Medicines Agency (EMA), as

the consequence of an absurd error in

the appointment procedure. But at this

stage, that news can be little more than

a lament. In a health policy world where

competition for profile is tough, a vacuum

at the top is a serious disadvantage. Until

a successor is appointed, the agency is

inevitably going to be limited to business

as usual—of which there is plenty, but

there was plenty more to be done on

forward thinking that will now be put on

hold. As soon as the situation becomes

clearer on who will take over at the head

of the EMA, this column will return to

exploring options for the new executive

director, and for the agency itself.

The new health commissioner

Meanwhile, to a new appointment

that also has major significance for the

world of health in general, and clinical

trials in particular, and where we do

know who is taking on the job. European

Commissioner for Health and Food

Safety Vytenis Andriukaitis has now been

anointed, and will be one of the key

influences on health legislation over the

next five years. His appointment follows

his gaining the backing of the members

of the European Parliament (MEPs) who

auditioned him for the job in October.

In his audition, he offered some clues

as to his approach, and articulated

them in a number of commitments.

Those MEPs are determined to hold

him to his word. So much so that they

have listed the commitments in a formal

document, quoting verbatim Andriukaitis’

observations to the parliament.

So we can now look forward to what

he may do with public health systems

reform. “I plan to continue work to assess

the performance of health systems and

underpinning advice on healthcare

systems reform,” he said. And in response

to population ageing and the growing

burden of chronic diseases, “I will

support efforts to make health systems

more efficient and innovative; so that

they can provide equitable healthcare to

all citizens, while remaining financially

sustainable.” On primary care and

e-health, “I will work on universal health

coverage, strengthening primary care,

improving quality and safety, promoting

e-health.” In support of prevention and

healthy lives, “I intend to put much focus

on enhancing prevention.” On bridging

inequalities in health, “I will seek to ensure

that every initiative on health contributes

to bridging the wide inequalities in health

that persist in Europe.”

On his role in enforcing health

legislation, he indicated his determination

to push forward the follow-up of the recent

European Union directive on patients’

rights in cross-border healthcare. This

is designed to allow a form of health

tourism, in which EU citizens can not only

go to other EU countries to be treated, but

can expect to be reimbursed for their care.

This is also the legislative measure which

has provided the first legal base for the EU

to work on health technology assessment

and on e-health.

The Ebola challenge

Andriukaitis said that he would “also work

with member states to protect citizens

against any cross-border health threat,

with an immediate focus on the Ebola

outbreak in West Africa.” That challenge

has grown in significance even since he

made the commitment, as the number

of deaths in Africa has risen, and as more

health workers have returned from the

region to be treated for infection. In fact,

Andriukaitis’ first trip since he took on

the job was to Guinea, Sierra Leone, and

Liberia, to make an on-the-spot evaluation

of the nature of that challenge.

His focus chimes with the EU’s broader

efforts to boost the developed world

response to the Ebola challenge. Already

the European Council has appointed the

new commissioner for humanitarian aid,

Christos Stylianides, as the coordinator

of the EU response, and the EU and its

member states have made more than $1

billion available for short- and medium-

term efforts. New money has been put into

developing new vaccines and treatments,

including some $300 million for a joint

EU-pharmaceutical industry initiative to

boost research into Ebola vaccines and

protocols for hospital-infection control.

At the same time, preparations are now

underway to start clinical trials for new

treatments for Ebola at three sites in West

Africa. The trials, run in partnership with

Médécins sans Frontières (MSF), could

yield initial results in early 2015.

M e a n w h i l e , t h e n e w h e a l t h

commissioner will have to make progress

with ensuring that EU legislation on

clinical trials and counterfeiting and

pharmacovigilance and a host of other

matters is satisfactorily put into effect

across the EU, as well as advance a series

of strategic discussions on how to make

health systems in Europe sustainable

while fostering innovation.

— Peter O’Donnell

Health Challenges Mount for EuropeRegion is facing a widening range of problems as the EU tackles external threats and internal changes

V I E W F R O M B R U S S E L S



NEWS

D A T A A N A LY S I S

G L O B A L R E P O R T

Based on a recently completed analysis,

the Tufts Center for the Study of Drug

Development (Tufts CSDD) estimates

that the cost to develop a new prescrip-

tion medicine that gains marketing ap-

proval is now $2.6 billion. This figure in-

cludes $1.4 billion in direct out-of-pocket

costs to develop the new prescription

drug, plus the high cost of drug failures

and the capitalized costs spent over a

lengthy drug development cycle time.

The estimated cost to develop an ap-

proved drug in 2003 is $1.04 billion (ex-

pressed in 2013 dollars). The updated $2.6

billion cost estimate represents an 8.5%

compound annual growth rate over the

2003 level. Factors that have likely con-

tributed to this high and rising cost to de-

velop an approved drug include larger and

more complex clinical trials and declining

drug development success rates.

— Tufts CSDD

Ella Fitzgerald always loved Paris in the

springtime, and the Drug Information

Association (DIA) is now hoping the

French capital will prove to be an irresist-

ible lure for the pharmaceutical industry.

For the 27th DIA Annual EuroMeeting, or-

ganizers have switched the event from its

usual late March slot to mid-April in 2015.

The congress will look at some of the

major challenges facing global health to-

day, including the need to come together

to drive innovation. The opportunity of

the Innovative Medicines Initiatives (IMI)

and other public-private partnerships are

formative mechanisms that must be maxi-

mized in Europe and other regions, pro-

gram chairs note.

Discussion at the meeting will con-

centrate on how early and harmonized

regulatory dialogue is necessary to en-

sure clinical development that is more

efficient and will accelerate access to novel

therapies for patients. The role of the Eu-

ropean Union’s new clinical trials legisla-

tion will come under scrutiny in the meet-

ing’s opening track on access to innovative

treatments.

Another track will look at special devel-

opment pathways in pediatrics, the elderly,

and in pregnancy. Nearly 10 years after

the adoption of the Paediatric Regulation,

substantial experience has been gained,

yet science continues to evolve in this area

and raises new questions to be answered

in the future. At the same time, the need

for global convergence has become evi-

dent in several areas. Also, the speed of

traditional development concepts is slower

than the speed of ageing in European so-

ciety, according to the theme leaders.

Further parallel sessions will focus on

innovation in vaccine development, medi-

cal devices, and combination products,

novel treatments for rare diseases, avail-

ability of medicinal products/drug short-

ages, pharmacovigilance, big data, and

mobile health, among other areas.

Paris has a rich history of medical in-

novation. Local scientists and clinicians

have changed modern medicine through

the discovery of instruments such as the

stethoscope and hypodermic needle,

treatments like antibiotics or antipsychot-

ics, vaccines against tuberculosis and ra-

bies, and the discovery of diseases such

as HIV.

—Philip Ward

The Cost to Develop an Approved New Drug Now Exceeds $2.5B

DIA Opts for Paris in the Springtime

Source: Tufts CSDD

$1,044

$2,558

2003 2013

($US millions expressed in 2013 dollars)

The Price of Innovation




To see more Clinical Trial Insights articles, visit


Good news: recent research among

a global public and patient

c o m mu n i t y s h ow s g e n e r a l

improvement in attitudes and

perceptions about clinical research.

Bad news: there is one group —

patients and the public in Europe—

with consistently more negative

opinions and views that appear to be

getting worse.

Based on nearly 850 responses, a

recent Center for Information & Study

on Clinical Research Participation

(CISCRP) study finds that the European

public considers clinical research to be

riskier than does the public in many

other global regions. Moreover, the

European community shows the lowest

sel f-assessed general k nowledge

about the clinical research process

and the lowest level of willingness to

participate in clinical trials. Among

European s tudy par t ic ipants, a

higher percentage finds the informed

consent form rev iew dif f icult to

understand relative to their geographic

counterparts. And study participants

in this community are among those

least willing to consider participating

in another clinical research study.

Although we can speculate, the

root causes of the problem are not

completely clear. A closer look at

the attitudes and perceptions in this

particular community strongly indicate

that much more focus and attention

is required to address underlying

concerns and implement targeted

outreach, education, and new patient

engagement initiatives.

Perceptions & insights

Between January and March 2013,

C I S C R P — a n i n d e p e n d e nt no n -

profit organization—developed and

conducted the “Perceptions & Insights

Study ” to resume and establish

routine global assessment of public

and patient perceptions, motivations,

and experiences with clinical research

participation. The online study was

conducted among a global community

of health information seekers and

research participants. A total of 5,701

international respondents completed

the survey, making it one of the largest

international clinical research surveys

ever conducted. Given the sample size,

generally a three to five percentage

point difference between subgroup

values is significant at the p<.05 level.

To reach a global community of

respondents, CISCRP collaborated

with Acur ian (now par t of PPD),

a worldwide prov ider of patient

recruitment and retention services—

for its help in reaching and engaging

respondents. Acurian maintains a

proprietary database of people who

have explicitly opted-in—via online

and offline consumer health surveys—

to receive healthcare information on

specific diseases and clinical trial

notifications.

The highest concentration (75%) of

respondents resides in North America;

15% are based in Europe, 5% from

South America, and another 5% from

Asia-Pacific. A majority of respondents

(58%) are female. Approximately four

out of 10 respondents in Europe and

in North America had participated in

a clinical trial prior to completing the

online survey. Respondents diagnosed

with an illness represented a broad

mix of disease indications.

Higher perceived risk

One out o f f ive people overa l l

considers their general knowledge

about clinical research to be poor, but

there is wide variation by geographic

r e g io n . A s i g n i f i c a nt l y h i g h e r

proportion of the public in the Asia-

Pacific and South American regions

views themselves as less informed,

with 28% and 31%, respectively, doing

so. But the European public considers

themselves to be the least informed,

with nearly half (47%) indicating so.

The European public views clinical

research as riskier than do their North

American counterparts. Approximately

one in 10 people in North America

believe that clinical research studies

are “not at all” and “not very’” safe.

This compares with nearly twice that

rate (18%) of the European public.

Almost 60% of the public in North

America and 53% of those in Europe

share the view that the possibility

of experiencing side effects is high

while participating in a clinical study.

A much larger propor t ion (27%)

of the European public believes

Kenneth A. Getz

MBA, is the Director of

Sponsored Research at

the Tufts CSDD and

Chairman of CISCRP, both

in Boston, MA, e-mail:

[email protected]

Education and Satisfaction Disparities Evident Among European Patients, PublicStudy spotlights the challenges and opportunities to better engage the patient community in Europe




that study participation poses risks

to one’s overall health compared

to approximately 20% of the public

in each of the other global regions

assessed.

General public w il l ingness to

participate in a clinical research study

is consistent with that seen in past

global surveys. At this time, a very

high proportion (87%) of the public

says that it is “somewhat willing”

and “ver y willing” to par tic ipate

in a clinical research study. The

European public shows the lowest

level of willingness to participate,

with only 58% indicating so in 2013.

This compares with 66% of the South

American, 73% of the Asia-Pacific, and

90% of the North American public.

A lower proportion of the public in

Europe is willing to participate in

clinical research today than did so in

2007 (71%).

Harder informed consent,

lower satisfaction

Among all respondents, one-out-

of-five study participants consider

the informed consent form to be

“somewhat difficult” or “very difficult”

to understand. But wide differences

are observed by global region: a much

higher proportion in Europe—four

out of 10 study participants or twice

the overall rate—found the informed

consent form difficult to understand.

In this one regard, study volunteers

in South America and Asia-Pacific

had the hardest time understanding

the informed consent form, with 63%

and 69%, respectively, rating their

informed consent forms “somewhat”

and “very difficult.”

O vera l l , nea r ly 6 0% of s tudy

volunteers repor t tak ing time to

read the informed consent form by

themselves. A signif icantly lower

p ercentage o f s tudy volunteer s

outside Nor th A mer ic a —30% of

South American, 46% of European,

and 23% of A sia-Pac i f ic —repor t

doing so. Approximately one in four

study volunteers read the informed

consent form with study staff; the

highest percentage (50%) reviews

the form with study coordinators.

A signif icantly higher percentage

o f s t u d y v o lu nte e r s i n S o u t h

A mer ica and A sia-Paci f ic rev iew

the informed consent form with the

principal investigator (39% and 48%,

respectively).

Among all sur vey respondents,

85% of study participants say they are

“somewhat satisfied” or “very satisfied”

that their questions were answered

during the informed consent form

review process, and 15% say that they

were not satisfied. A significantly

higher percentage (approximately one-

third) of European study volunteers is

not satisfied that their questions were

answered during the informed consent

review process.

L ast ly, in the agg regate, the

over whelming major it y (95%) of

study volunteers say that they would

consider par ticipating in another

clinical research study in the future.

The percentage willing to participate

has increased by 10% since 2007.

But a significantly lower proportion

of European study volunteers (80%)

share the sentiment. Having been

through the clinical trial participation

experience, compared with those in

other global regions, European study

volunteers are among the least likely

to participate in another study in the

future.

A targeted response

These results, and many more found

in the 2013 CISCRP “Perceptions

& Insights Study,” indicate that

there is an urgent need and a major

opportunity to educate and engage the

European public, patient, and study

volunteer communities. There are

unique cultural and societal factors

contributing to these conditions in

Europe. Broad exposure to highly

visible and tragic patient deaths in

Europe assoc iated w ith c l inic al

research studies in the not-so-distant-

past, and the af termath of these

events, have shaped public attitudes

and perceptions.

For a variety of reasons, European

public attitudes and perceptions have

not rebounded during the past seven

to 10 years as have those among the

Nor th American public. This may

be a function of more frequent and

active public outreach and education

in North America. Clinical research

professional awareness of— and

the desire to execute —practices

and initiatives that enhance study

volunteer experience and establish

higher levels of engagement may be

relatively lower in Europe at this time.

The e f for t s o f The Europ ean

Patients‘ Academy on Therapeutic

Innovation (EUPATI)—a consortium

funded by the Innovative Medicines

Initiative—are much needed to help

address the educational disparities

among patients and study volunteers

in Europe. CISCRP has also turned its

sights on the European community

with a planned launch of its AWARE-

for-ALL public awareness and outreach

live event in London in spring 2015.

CISCRP hopes to spread its programs

and initiatives across all of Europe

during the next several years. The

European Medicines Agency’s (EMA)

commitment to improve disclosure

and transparenc y—most notably

the distribution of lay language risk-

management plans and clinical trial

results summaries—will help improve

public trust and position Europe as

the global leader on this front.

CISCRP hopes to assist the clinical

research enterprise in monitoring

trends and identifying opportunities

to better inform and engage the public

and patients as stakeholders and

partners. In early 2015, CISCRP will

be launching its second “Perceptions

& Insights Study,” with an eye toward

increasing the number of respondents

from Europe and other parts of the

world.

ES542745_ACT1214_013.pgs 12.10.2014 21:04 ADV black


CLINICAL TECHNOLOGY

14 APPLIED CLINICAL TRIALS appliedclinicaltrialsonline.com

PEER

REVIEW

The Future of ePRO

PlatformsAlan Yeomans

It is tempting to imagine the use of the patient’s

own mobile computing platform for collection

of patient-reported outcomes (PROs). This would

solve some of the problems faced when using the

electronic PRO (ePRO) devices employed today:

• Provisioning costs (purchasing or leasing the de-

vices to be used in the trial)

• Supply issues (delivering the devices to the sites

for distribution to subjects, and collection after the

subject completes the trial)

• Training (handling and use of the device by sub-

jects and site staff)

• Maintenance and Help Desk (device-related help

desk questions, replacement of faulty devices)

This article evaluates the practicality of such an ap-

proach, and the issues that need to be addressed if it

is to succeed.

Present state of the art

The goal of a PRO system is to collect data directly

from subjects; data used to measure the benefit of

treatment or the risk in medical clinical trials.1 Initially,

this was done using a pen and paper, and patient

responses were collected in the form of surveys con-

ducted once (or a few times) during a trial and/or in

the form of a patient diary, containing responses col-

lected regularly throughout the trial.

The move toward ePRO solutions, which started in

the 1990s, was fueled by a number of considerations,

primarily:

• Improved compliance through the use of alarms,

reminders, and date and time stamps

• Improved data quality through the use of electronic

data collection and in-built data checks

• Reduced trial times due to quick access to data

without requiring data transcription

Interestingly enough, cost has not been one of the

primary movers. Although most companies adopt-

ing ePRO have had hopes that improved compliance,

data quality, and reduced trial times in themselves

would lead to cost savings, these are cost savings

that are difficult to quantify. Indeed, often the move

to ePRO involved higher up-front costs, with eventual

savings being realized later in the trial process.

ePRO solutions diverged early along two paths. The

simplest and most cost-effective tools have been the

interactive voice response systems (IVRS), but these

have had restrictions in their functionality, the user

interface, and the type of data that can be collected.

In order to support the collection of more compli-

cated data, a number of vendors developed solutions

that could support entry of textual and graphical

data.2 These solutions were based on proprietary

software running on commercially available electronic

platforms, or “device-based applications.” Initially,

these solutions were based on commercially available

personal digital assistants (PDA) platforms. The earli-

est were based on the Apple Newton PDA, followed in

the late 1990s by systems using the Palm Pilot. These

all used offline synchronization techniques, making

it necessary to store data temporarily on the device

itself, initially until the next time the patient visited

the clinic. Later on, solutions were developed that

allowed subjects to synchronize remotely (e.g., from

home). GSM-enabled PDA devices were introduced

in the early 2000s, allowing continuous synchroniza-

tion (as long as the subject was within reach of a GSM

network).

The one thing in common for device-based ap-

plications is that they used proprietary software in-

The practicality and benefits of using a subject’s own mobile device to collect patient-reported outcomes.



CLINICAL TECHNOLOGY

stalled on a commercial platform. This necessitated supplying

subjects with the devices to be used for the study in question,

training them in the use of the devices, and collecting the devices

from the subjects as they complete or withdraw from the trial.

Because device-based applications store the application itself

and in many cases act as a temporary store for the data then

there are special requirements that need to be addressed by

these solutions.1,3 The software must prevent end users from:

• Modifying the application or the data stored on the device

• Installing and using other applications that may influence the

device-based ePRO application or the

data collected by it

• Deleting the ePRO application and

using the device for other purposes

The device-based applications often

use hardware specific capabilities in or-

der to fulfill the above requirements,

which results in new aspects that need

to be considered:

• The ePRO software can only be used

on hardware platforms that support

the capabilities used1,3

• Every release of the device-based ap-

plication needs to be validated with

every release of the hardware it is

used on to ensure that the software

operates as required (e.g., the user is

still blocked from deleting data on the

device)1,3

PRO instruments and requirements

A PRO instrument is the collection of

questions and scales used to elicit in-

formation from the subject. It is not

dependent on technology as such—a

PRO instrument can be implemented on

paper, using an ePRO solution or both.

However, there is a regulatory require-

ment that the PRO instrument be shown

to measure the correct information to

support later uses of the PRO data, for

example, in labeling claims. Typically

this is shown by validating the PRO in-

strument.1,3,4

One concern has been that a PRO

instrument that has been validated in

one implementation (usually on paper)

may not produce the same results if it

is transferred to a new medium (such as

ePRO). The concern has been that dif-

ferences in layout, the presentation of

the question, the number of questions

presented at the same time, and the

size of scales and other similar aspects could influence patient

responses. One large study (looking at 46 trials and 278 scales)

was carried out to investigate these concerns.5 The conclusions

reached were that the responses collected from the subjects

were comparable even when using different media (paper, ePRO).

Other similar studies6,7 have shown that minor changes caused by

changing from one media or device to another did not adversely

affect the results, but larger variations in the presentation, such

as rewording or reordering the instrument, could result in the re-

sults not being comparable.

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CLINICAL TECHNOLOGY

New technology

We now have a potential pool of subjects for clinical trials to

whom the use of web-based software and mobile computing

platforms is commonplace. Web-based applications are now to

be found in most users’ Internet histories—buying goods and

services online, social media, and personal banking are web-

based services now used by most of us.

Connectivity and computing power are areas that have seen a

dramatic development and evolution in the last five to 10 years.

Smartphones and tablet computers that are more powerful than

the desktop computers we used just a few years ago are gaining

market shares. According to reports from Gartner8 and Statista,9

worldwide smartphone sales in 2012 amounted to a little more

than 722 million units, of a total 1.746 billion mobile phones sold.

In 2013, smartphones were projected to account for 958 million

of a total of 1.8 billion mobile phones sold. In addition, by 2015,

tablet computer sales are estimated to reach 325 million, while

PC sales continue to decline (see Figure 1).

As these trends show, more subjects recruited for clinical trials

will have advanced mobile computing platforms, platforms that

are more advanced than today’s ePRO devices. The standardized

delivery of software installed on the client platform (computer,

smartphone, or tablet) has also been revolutionized by the use of

“apps,” which are now even used to install software on other con-

sumer products such as Smart TVs. This enables the easy delivery

(over the Internet) and installation of proprietary software on the

consumer’s own device.

App or web-based application?

What are the advantages and disadvantages of the two new tech-

nology solutions that offer us the possibility of using the patient’s

own device—web-based applications and apps?

Validation

A web-based application requires validation for every sup-

ported combination of operating system (i.e., iOS, Android, Win-

dows) and browser (i.e., Safari, Chrome, Internet Explorer, etc.).

There is little or no requirement for device-specific validation.

When using apps, there are still some differences between

platforms and devices. The user does not have to look far to find

examples of apps that run on some phones and tablets but not

on others.10 Hence, the introduction of the “app” methodology

has helped standardize the software environment, but the basic

validation requirement is still the same—the instrument must

be validated on every type of mobile phone, tablet, and computer

used in the trial.

Offline

The greatest single disadvantage of a web-based application

is that you must have Internet connectivity in order to use it. The

latest HTML standard (HTML 5) has introduced limited offline

capabilities, but you still need an Internet connection to submit

and store the data once the questionnaire has been completed.

The use of a local app allows for local storage of data and

synchronization with a central database at a later time when

connectivity is re-established. This is a well-established method

used by existing legacy solutions and accepted by the regulatory

authorities. The only major risk (which is the same for existing

legacy solutions) is the risk of losing data if the device is lost or if

it should break down.

Installation

A web-based application has a zero footprint on the patient

device and no need for local installation on the patient device.

A local app does require installation, and although modern

systems (iOS, Android, and Windows) have simplified the down-

loading and installation of apps, it still must be done. And this

also brings into play a range of requirements mentioned earlier

regarding device-based applications:

• The need to prevent patients from modifying the app or the

data stored on the device

• The need to prevent patients from installing and using other

apps that may influence the ePRO app or the data collected.

• The need to prevent patients from deleting the ePRO app

A web-based application simplifies the use of ePRO instru-

ments in all cases except when an offline capability is of vital

importance to the trial. Although the use of an app simplifies the

Source: Yeomans

Figure 1. Comparing worldwide mobile platform market shares in 2012 versus estimates for 2015.

Mobile Momentum



CLINICAL TECHNOLOGY

distribution and installation of software and can help ensure that

the ePRO instrument looks the same on all supported devices, it

does not address the other issues facing the legacy device-based

applications, as an app is after all still basically a device-based

application.

The use of app technology is an improvement on the existing

legacy device-based applications, but it is not a radically new

idea—it is simply a standardized environment for the distribu-

tion of, installation of, and the operating system for computer

software. It is a step toward the future in software development

in general that started with the use of Linux (which also delivers

all three of those benefits, although the use of Linux is limited for

mobile computing platforms).

The future of ePRO platforms can be even brighter when con-

sidering web-based applications.

The issues

We want to collect PROs in a fashion that ensures the data col-

lected is correct, dependable, and repeatable, in terms of both:

• Producing comparable responses from the same subject over

time

• Producing data that is comparable between subjects

There are a number of challenges to be faced if we want to use

the possibilities presented to us by the spread of smartphones

and tablet computers.

One of the most important issues is that of validation of

the PRO instrument. Attempts to use the subject’s own mobile

phone for ePRO have often been rejected due to problems with

validation of the PRO instrument. The arguments used include:

• How does the sponsor show that the data collected sup-

ports their claims, when subjects are using different devices,

with different sized screens and varying graphical interfaces?

• How can they ensure that the results are comparable except

through validation of the instrument on every type of mo-

bile phone used in the trial?

The cost of such a validation effort is prohibitive.

The solution

The studies mentioned earlier5,6,7 give a clue to how such a

situation can be handled. Their findings indicated that minor

changes in appearance of the PRO instrument still produced

comparable results. This can be leveraged by ensuring that:

1. Devices with comparable capabilities are used. Smart

phones and mini-tablets all have similar sized screens, similar

graphic resolutions, and similar colors.

2. The PRO instrument needs to utilize a common graphi-

cal denominator that appears the same on all devices (e.g.,

all answer choices are shown without scrolling). When using

larger tablet computers and PCs, then the same limited area

should be used for display as on smart phones and mini-

tablets.

3. The use of a single application across all devices ensures

the same “look-and-feel” within the PRO instrument with re-

gards to ordering and presentation.

4. The use of a web-based application would mean there was

no software installation required on the subject device.

5. The use of a web-based application counteracts the need

for computer system validation on each possible platform.

The study protocol and the design of the PRO instrument

should take into account the need for comparability in responses

across slightly different devices, and, thus, avoid cases that could

potentially create difficulties. The use of advanced graphical

scales, such as graphical body representations (e.g., point at the

part of your body that is in pain) is generally considered to be

more dependent on exact equivalence in the graphical represen-

tation than textual questions and answers. To ensure compli-

ance across multiple devices, the body could be divided up into

different areas (head, shoulder, etc.) that are highlighted if the

subject clicks on any part of that area.

How many of the prospective subjects in our clinical trials

have their own smartphones? Market analysts predicted11,12 that

the major pharmaceutical markets will pass 50% market pen-

etration for smartphones from 2012 to 2014. If a subject group

contains subjects that do not own a device suitable for use in the

trial, then a mixed model can be used. The advantage of a “sub-

ject’s own device” model is that it implicitly allows for varying

devices to be used in the same trial. One advantage is that even

EFGCP Annual Conference 2015

How do we Improve Health without %HWUD\LQJ�&RQÀGHQWLDOLW\�ZLWKLQ�&XUUHQW�and Upcoming EU Regulations?

27 & 28 January 2015 – Brussels, Belgium

WHAT IS THE PRICE OF MAINTAINING CONFIDENTIALITY

FOR PATIENTS IN HEALTH RESEARCH?

This has been recognised within the dis-

cussions around the new EU Clinical Trial

Regulations but it could be irreparably

damaged by proposed Data Protection

Regulations. The use of personal health

data in research would become impossible

in practice.

The conference will seek to strike a

balance in answering the key questions.

Overview

Progress in our understanding of the

factors underpinning good health is

leading us towards developing better

treatments. Much of this advance is

founded on the use of personal data.

Without access to this data, medical

progress would be seriously impeded and

proposed restrictive access to

clinical information poses a serious,

immediate threat to research. There is

a real danger we will sleepwalk into a

position where we undermine health

research designed to provide health care

EHQH¿W�

Objectives

�� A description and report on data

protection arrangements in research

across the EU through the EFGCP

Research Ethics Committee survey

��Debate on and development of a draft

statement on secondary use of data in

research

�� EFGCP report and recommenda-

tions that will be provided to those

involved in the legislative process.

To follow the development of the

programme or for any information

on registration, please visit

www.efgcp.eu or contact us at

[email protected]

www.efgcp.eu



CLINICAL TECHNOLOGY

if a subject changes device in mid-trial (e.g., purchases a new

smartphone), then data compliance is still maintained.

Regulatory aspects

It is absolutely essential that any system used to collect data for

clinical research is compliant with the regulations and guidelines

covering this work. So when evaluating the use of new technol-

ogy, it is especially important to highlight the areas that differ

from existing solutions, and whether these areas require special

consideration in order to ensure regulatory compliance.

The use of a web-based software application instead of a

device-based application does not alter the fact that the soft-

ware used needs to be documented and validated in exactly the

same way as all software in the industry is handled. It is also the

responsibility of the investigator and trial sponsor to formally

document a risk assessment (Quality Risk Management Plan) for

the continuity of data entry when a subject loses his or her device

or decides to get a new one. This already applies even when us-

ing legacy device-based applications, hence, there are no extra

burdens when moving to a solution based on the patient’s own

mobile computing platform.

When using a legacy device-based application, it is vital that

the user cannot influence either the application or the data

stored locally. An important functionality (and validation step) to

be considered when developing device-based applications is how

to disable user access to the software and data, and validating

that there is no way the user can get at the software or data.

The following problems when using device-based applications

are automatically solved by the use of a web-based application:

• Loss of data due to loss of device or device malfunction

• Collection of incorrect data due to the latest protocol amend-

ment not being implemented on the device

The solution of these issues for device-based applications

involves additional software, and, therefore, additional validation

effort and additional risk.

Using the patient’s own mobile computing platform provides

substantial savings from a regulatory compliance point of view.

There is no software installed on the remote device, nor is any

data stored. Therefore, the fact that the patient’s own device is

being used becomes almost unimportant—as long as it supports

the web-based application, no further validation is required.

Platform support can be programmed into the web-based ap-

plication itself in the form of requiring certain versions of given

browsers; if they are available on the patient’s device, then there

is no problem. The use of the patient’s own device then becomes

directly analogous to the use of a telephone in an IVRS system—

there are no requirements to validate IVRS systems against all

possible telephones in all countries in the world; it is enough that

standard telephone functionality is available to the subject.

Summary

What are the advantages that a subject’s own device solution

offers? The major advantages were named in the opening para-

graph, namely provisioning, supply, training, and maintenance.

When would the legacy IVRS and device-based applications be

more suitable? IVRS solutions do not require a mobile computing

platform; they operate on any telephone. In this respect, they are

still applicable for all potential subjects that have access to a tele-

phone, but not to a smartphone, tablet computer, or PC. This is

currently a large, but diminishing, proportion of the overall pool

of subjects. Device-based applications can still be the solution

of choice for trials with specific requirements for a uniform hard-

ware solution. One example is a requirement to connect to exter-

nal equipment at the subject’s residence, such as PEF meters and

blood pressure cuffs.

The future is already here

It would appear that there are few, if any, insurmountable prob-

lems with the use of the subject’s own device. If the study pro-

tocol and the PRO instrument have been designed with this in

mind, then the ePRO comparative studies already conducted1,6,7

indicate that the subject’s own device can be used.

Traditionally, large corporations in the clinical research sector

exhibit a certain resistance to adopting new technologies, but

are there any regulatory or other substantial concerns that would

contraindicate adopting the patient’s own mobile computing

platform for ePRO? As can be seen from the previous summary,

the answer is no.

So why isn’t this already being done? Actually, it is—all

around the world, trials are presently being run that collect ePRO

data in this fashion, including studies critical to regulatory sub-

missions. The FDA1 and the European Medicines Agency (EMA)4

have issued guidelines and reflection papers, which outline their

current thinking when it comes to compliant use of ePRO.

Examples of studies using a web-based application on the

patient’s own mobile computing platform include:

• A Phase II clinical trial in the U.S. testing the use of a new

pharmaceutical designed to increase sexual desire, arousal,

and satisfaction in females with sexual desire disorder. The

ePRO data contains primary efficacy data as the measure

of success of the treatment and is heavily dependent on the

qualitative responses from the subjects. The trial included

more than 200 subjects at more than 15 sites in the U.S.

• A medical device trial in Europe to evaluate an additive for

pain relief in a plastic surgery product used for cheek shaping.

Again, the ePRO data containing primary efficacy data as the

measure of the degree of pain relief is heavily dependent on

the qualitative responses from the subjects. The trial included

more than 50 patients at three sites.

• An investigator-initiated Phase IV trial in Japan to test the ef-

ficacy and safety of three types of hyaluronic acid injections

into patients with osteoarthritis of the knee. The ePRO data

collected is a quality of life questionnaire containing the

WOMAC scale. The trial included more than 600 patients at 30

sites.

If the design of the study protocol and the PRO instrument



CLINICAL TECHNOLOGY

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aims at being comparable across different devices, and the study

population is chosen such that the subject’s own device can be

used for data collection, then clinicians can run one of the new

breed of ePRO trials already out there.

References

1. U.S. Department of Health and Human Services. “Patient-Reported

Outcome Measures: Use in Medical Product Development to Support

Labeling Claims.” December 2009.

2. Vendors of e-PRO device-based solutions: PHT Corporation— http://

www.phtcorp.com, eResearch Technology (incorporating Invivo Data

and Clinitrac)—http://www.ert.com/CRF Health—http://crfhealth.com

3. European Commission Health and Consumers Directorate-General.

Annex 11: Computerised Systems from EudraLex, “The Rules Govern-

ing Medicinal Products in the European Union,” Volume 4 Good Manu-

facturing Practice, Medicinal Products for Human and Veterinary Use

4. EMA Committee for Medicinal Products for Human Use. Reflection

paper on the regulatory guidance for the use of health-related quality of

life (HRQL) measures in the evaluation of medicinal products; EMEA/

CHMP/EWP/139391/2004

5. Gwaltney CJ, Shields AL, Shiffman S. “Equivalence of Electronic and

Paper-and-Pencil Administration of Patient-Reported Outcome Mea-

sures: A Meta-analytic Review.” Value Health 2008;11:322-33.

6. Coons SJ, Gwaltney CJ, Hays RD, et al. “ISPOR ePRO Task Force Recom-

mendations on Evidence Needed to Support Measurement Equiva-

lence Between Electronic and Paper-based Patient-reported Outcome

(PRO) Measures: ISPOR ePRO Good Research Practices Task Force

Report.” Value Health 2009; 12:419-29.

7. Juniper EF, Langlands JM, Juniper BA. “Patients May Respond Differ-

ently to Paper and Electronic Versions of the Same Questionnaires.

Respir Med 2009;103:932-4.

8. Gartner: Gartner Says Worldwide Traditional PC, Tablet, Ultramobile

and Mobile Phone Shipments On Pace to Grow 7.6 Percent in 2014,

http://www.gartner.com/newsroom/id/2645115

9. Statista: Global smartphone shipments from 2010 to 2017 (in million

units), http://www.statista.com/statistics/263441/global-smartphone-

shipments-forecast/

10. “Fitbit” is an example of a common App available for both iOS and

Android that does not support all devices on either platform, see:

http://www.fitbit.com/uk/devices

11. Nielsen: Mobile Majority U.S. Smartphone Ownership Tops 60%, http://

www.nielsen.com/us/en/newswire/2013/mobile-majority--u-s--smart-

phone-ownership-tops-60-.html

12. eMarketer: Smartphone Adoption Tips Past 50% in Major Markets

Worldwide, http://www.emarketer.com/Article/Smartphone-Adoption-

Tips-Past-50-Major-Markets-Worldwide/1009923#BDPmZj33rlE8f

TVX.99

Alan Yeomans is Quality Manager, Pharma Consulting Group, email: Alan.

[email protected].

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CLINICAL TECHNOLOGY

20 APPLIED CLINICAL TRIALS appliedclinicaltrialsonline.com

PEER

REVIEW

How Mobile Technology is Evolving in Clinical TrialsTim Davis

It is estimated that mobile penetration now stands

at 96% globally, with significant growth in sub-

scriptions in the developing world in recent years,

increasing from 69% of the population in 2011 to

89% in 2013.1,2 As access to devices expands across

the globe, the use of mobile technology in all walks

of life has become commonplace. As a result, mobile

communication has been leveraged to provide infor-

mation and access to services across multiple indus-

tries, from simple applications such as checking train

timetables to mobile banking with secure access to

personal information in a highly regulated industry.

Clinical research is no exception to this trend and, in-

deed, the drug industry has seen an increasing move-

ment to leverage mobile technology to engage with

patients and collect their data during clinical trials.

The evolution of mobile in clinical research

In many ways, the inclusion of mobile phones and

other devices in the clinical arena has been an evolu-

tion. The first step began almost a decade ago with

the use of short message service (SMS) messages

to address the retention and compliance issues so

commonly faced during research. The scale of the

problem was accurately brought home in a recent

article in the Drug Information Association’s (DIA)

journal, Therapeutic Innovation & Regulatory Science, which

revealed that as many as 30% of clinical trial partici-

pants do not take their study medication correctly.3

The main reasons cited for non-adherence include

forgetfulness;4 poor communication with healthcare

professionals,5 especially in remote locations; and

absence of symptoms.6 An additional challenge is to

retain subjects for the duration of the trial and reduce

the number of patients lost to follow-up. In its recent

“Perceptions and Insights Study,” the Center for Infor-

mation and Study on Clinical Research Participation

(CISCRP) found that patients who drop out of clinical

studies tend to be less self-motivated, less confident,

and less understanding of the process.7

Mobile technology provided a means for research-

ers to communicate with patients remotely between

site visits through a medium that patients carried

with them wherever they were. It provided an effec-

tive system for sending reminders to ensure timely

actions such as clinic visit attendance, fasting, correct

drug intake, etc., while also establishing the means to

communicate much more broadly with the patient,

serving as a two-way open communication channel

that allowed patients to respond to prompts as ap-

propriate. This was the first step toward mobile elec-

tronic patient-reported outcome (ePRO) collection.

The introduction of these “retention and compli-

ance” services enabled sponsors to monitor safety,

manage compliance, and ensure patient retention

throughout the study. For example, in a cardiovascu-

lar outcome event monitoring trial, a mobile commu-

nication service was included to help maintain con-

tact with patients between subject visits, with a view

to increasing the likelihood of the patient reporting if

and when an event occurred. The use of this mobile

service resulted in a 5% increase in visit compliance

and a 4.5% reduction in early patient withdrawal com-

pared to those not using the service. Moreover, in a

study of 13,000 patients, it was estimated that if used

across the entire study, this would have equated to a

four-month earlier finish, resulting in the pharmaceu-

tical sponsor saving more than $14 million in costs.8

Analyzing the emergence of mobile customization in meeting the specific requirements of studies.



CLINICAL TECHNOLOGY

The rise of mobile ePRO solutions

The rise of mobile ePRO tools has transformed the way patients

engage in clinical trials. The ability to provide familiar technology

to patient populations facilitates the collection of time-stamped

data, and as mobile technology has propagated across the globe,

it serves as an ideal mechanism for communicating and collect-

ing data from hard-to-reach patients in developing markets such

as Eastern Europe, Asia Pacific, and Latin America.

With patient compliance rates typically as low as 55%,9 it is

important to ensure the simplicity of the data collection inter-

face. ePRO solutions can provide a simple, familiar, and effec-

tive modality to communicate and collect data and information

from patients. As users are already familiar with the technology,

they can navigate familiarly through the different steps of the

data-collection process. As a result, these tools facilitate simple,

real-time, and reliable collection of data from study participants,

regardless of age or demographic.

Mobile ePRO solutions can be customized to suit the specific

requirements of each trial. The assessment could be a series of

text messages sent intermittently to a patient’s mobile phone

to deliver online questionnaires, which can then be answered

instantly via the mobile device. Alternatively, assessments can be

delivered via an app—a route which is particularly useful when

patients are in regions likely to have limited connectivity; data

can be stored within the app and transmitted when connection

is available. The use of an app also enables automated connec-

tion to medical devices such as blood glucose meters and spi-

rometers via Bluetooth connections.

Mobile also allows for the inclusion of validated instruments

in PRO. To achieve this, the author must approve the use of the

scale in question; this is typically achieved through a usability

study to ensure patients can interact with the electronic ver-

sion and a validation study to assess equivalence compared to

existing modes of delivery. An example of such a study is the

m-WOMAC Osteoarthritis Index, which was found to be valid and

reliable using a simple mobile phone Internet connection, show-

ing no difference between mobile and paper scores.10

Introducing BYOD into clinical research

The traditional model for collecting ePRO measures has been

to provision devices, seeking the assurance of fixed parameters

for data viewing and validation. Until recently, this option has

been fairly restrictive, providing a single device to all populations

across each trial, regardless of their familiarity with the technol-

ogy. However, advances in technology have enabled the onset of

a “bring your own device” (BYOD) approach through the ability

to recognize device parameters and optimize the configuration

of data according to the device in use (e.g., laptop, tablet, mobile

phone). The growth of digital and mobile technology means that

many patients already own a device that can be used during the

study. Device analysis can easily be integrated into patient en-

rollment and device provisioning can typically be reduced to as

little as 10% or 20% of study participants. In some cases, this ap-

proach will remove the need for provisioning altogether such that

the patients’ own devices are employed throughout the study.

A BYOD approach delivers a cost-effective strategy to engage

patients through sharing information and capturing data on their

own devices. The requirement to provide devices is reduced, or

even removed altogether, as is the logistical challenge of manag-

ing large quantities of devices across the globe. An illustration of

the cost savings that can be achieved is shown in Figure 1.

The first step toward BYOD was taken in late phase trials,

where collecting real-world evidence from diverse populations

is often especially challenging. Unlike the small populations that

are closely managed by clinical trial sites in pre-approval clini-

cal research, late phase studies require management of large,

diverse populations by physicians and healthcare professionals

(HCPs) over long periods of time with fewer “touchpoints.” As a

result, providing patients with hardware for electronic data cap-

ture (EDC) has historically been cost-prohibitive, so trials began

to include online self-reporting as an alternative to paper data

capture.11 It is now possible to extend this BYOD opportunity

through platforms designed to capture data securely from any

connected device. Through recognizing the device being used

and optimizing the content accordingly, identifying personally

identifiable information (PII), and having internal procedures in

place to secure this PII, a BYOD approach can be used with confi-

dence as part of an efficient clinical strategy.

While there are existing examples of pre-approval BYOD use,

such as the vaccine trial case study highlighted on the next page,

the final stage in the evolution of mobile in clinical trials will be

the broad use of a BYOD approach in Phase II and III trials. This

is currently a hot discussion topic across the industry.12,13,14,15 Exist-

ing evidence supports scale equivalence across multiple modali-

ties, such as the PROMIS study using interactive voice response

(IVR), paper, personal digital assistant, and computer,16 and the

ability to identify exact specifications of devices in use (screen

size, operating system) and to block their usage if they fall out-

side of the validation range.

Source: Davis

Figure 1. Cost comparisons between paper and

electronic-based reporting tools.

Cost Savings



CLINICAL TECHNOLOGY

Reshaping the industry

Assessing the current landscape of the pharmaceutical industry,

it is evident that mobile technology has a large role to play in

improving the quality, simplicity, and ease of use of ePRO across

the clinical-to-real-world continuum. The opportunities mobile

solutions hold for the industry are vast, with the potential to

reduce the major financial burdens as a result of increasing pres-

sure to accelerate the path of drug candidates through clinical

trials. In late-phase and real-world studies, especially, where ad-

herence is often a major issue, mobile solutions provide an op-

portunity to incorporate patient engagement features to increase

adherence and, as a result, collect more accurate, unbiased data.

Mobile technology is increasingly being implemented as a

means of communicating directly with patients across broad

demographics and multiple locations in both clinical studies

and healthcare programs. The familiarity and universal nature of

mobile devices and the ability to select the right tool according

to the type of study that is being conducted, region, and demo-

graphic, makes the technology well-placed for integration into

global markets.

Case study—BYOD in a vaccine surveillance study

Study overview: A Phase III, observer-blind, randomized, multi-

country, non-influenza vaccine comparator-controlled study to

demonstrate the efficacy of an influenza candidate vaccine ad-

ministered intramuscularly in 3,150 healthy children six months

to 35 months of age across multiple countries in Europe.

The primary endpoint for the study was the efficacy of vac-

cine in the prevention of RT-PCR confirmed influenza A and/or

B disease for any seasonal influenza strain, when compared to

non-influenza control vaccines.

Data capture solution: The use of a BYOD approach offered parents

the flexibility to use their preferred means of contact for complet-

ing diary entries. Eighty-four percent of parents/guardians opted

to use their own mobile phone or personal computer, thus vastly

reducing provisioning requirements for the study.

Results: The use of EDC provided greater resource efficiency and

timelier follow-ups for the research team, as the switch from

weekly to daily contact was symptom-driven, and, therefore,

management would have been immensely complicated and

resource-intensive using paper.

Given the study’s scale and geographic spread, 100% pro-

visioning would have been cost-prohibitive, both in terms of

purchase of devices, as well as the associated logistics, mainte-

nance, and support necessary. With 84% of parents/guardians us-

ing their own device, the BYOD enabled a data capture method

that previously was not possible. Parents/guardians benefitted

from a user-friendly interface (with automated decision-making

via branching logic in the eDiary) and being able to contribute

from the familiarity of their own device (minimizing end-user

training). They were able to complete assessments and report

outcomes throughout the trial in the simplest possible way. This

empowered parents/guardians to steer their participation and

ultimately improve their child’s health. It also enabled high levels

of data entry compliance. Considering that the average provision-

ing cost per device (including setup, monthly data charge, and

monthly lease) was $400, the savings were clear to see—and

were expected to total almost $3 million upon study completion.

References

1. International Telecommunication Union, “ICT Facts and Figures: The

World in 2013,” http://www.itu.int/en/ITU-D/Statistics/Pages/facts/

default.aspx

2. International Telecommunication Union, “ICT Facts and Figures: The

World in 2011,” http://www.itu.int/ITU-D/ict/facts/2011/material/ICT-

FactsFigures2011.pdf

3. D.L. Smith, “Patient Nonadherence in Clinical Trials: Could There Be

a Link to Postmarketing Patient Safety?,” (2012), Therapeutic Innovation &

Regulatory Science.

4. L.R. Martin, et al., “The Challenge of Patient Adherence,”(2005), The

Clinical Risk Manager.

5. G.A. Hamilton, “Measuring Adherence in a Hypertension Clinical

Trial,” (2002), European Journal of Cardiovascular Nursing.

6. E. Vermeire, et al., “Patient Adherence to Treatment: Three Decades of

Research. A Comprehensive Review,” (2001), Journal of Clinical Pharmacy

and Therapeutics.

7. The 2013 CISCRP Perceptions & Insights Study, “Report on Ineligible

Participants and Those Who Terminate Participation Early,” (2013),

http://www.ciscrp.org/professional/reports/

8. Exco InTouch Internal Data.

9. H.B. Bosworth, “ Patient Treatment Adherence: Concepts, Interven-

tions and Measurement,” (2005), Routledge.

10. N. Bellamy, et al., “Osteoarthritis Index Delivered By Mobile Phone

(m-WOMAC) is valid, reliable, and responsive,” (2011), Journal of Clinical

Epidemiology, 64(2) pp182-190.

11. P. Wicks, et al., “Accelerated Clinical Discovery Using Self-Reported

Patient Data Collected Online and a Patient-Matching Algorithm,”

(2011), Nature Biotechnology, 29 pp411-414.

12. http://www.mct-congress.co.uk/pane/programme/

13. Can BYOD and Smartphones Move Clinical Trials Forward? http://

www.cio.com/article/736096/Can_BYOD_and_Smartphones_Move_

Clinical_Trials_Forward_

14. Device Independence is the Future of Clinical Trials. http://www.applied-

clinicaltrialsonline.com/appliedclinicaltrials/Trial+Design+Articles/

Device-Independence-is-the-Future-of-Clinical-Tria/ArticleStandard/

Article/detail/828040

15. “Electronic Clinical Outcome Assessments: Coming to a Device Near

You!” DIA Annual Meeting 2014, advertised program at http://www.

diahome.org/en-GB/Flagship-Meetings/DIA2014/Meeting-Program/

Find-Sessions-and-Presentations.aspx

16. J.B. Bjorner, et al., “Method of Administration of PROMIS Scales Did

Not Significantly Impact Score Level, Reliability, or Validity,” (2014),

Journal of Clinical Epidemiology, 67(1) pp108-113.

Tim Davis is CEO and Co-founder of Exco InTouch; email: tim.davis@

excointouch.com.



CLINICAL TECHNOLOGY

appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 23

PEER

REVIEW

Steps for a Successful Clinical Trial Management SystemErika Stevens, Christina Eberthart, Jim Moran

As the importance of translational research

continues to grow, with focus placed on com-

parative effectiveness and outcomes-based re-

search through translational science awards1

and the American Recovery and Investment

Act,2 research institutions are exploring other op-

tions to remain competitive players in the academic

clinical research arena. Among the options, many

academic institutions are partnering with the federal

government and industry to reinvest in bench re-

search and clinical trials.3,4 The results of this invest-

ment have been an increase in the number of clinical

research trials being conducted simultaneously, as

well as a rise in the number of investigational prod-

ucts (including devices and biologics) being tested.

This combined effort has placed a compliance bur-

den at academic research institutes (AMIs) or aca-

demic health centers.5 To mitigate compliance issues

and gain operational efficiencies, many academic

centers are implementing clinical research software

solutions to assist in managing the flow of informa-

tion in their growing clinical research portfolios.

Exploring the benefits of clinical trial

management system

As mentioned above, academic research institu-

tions are assessing options to better control the

flow of information and mitigate compliance issues

in non-clinical and clinical research trials. One op-

tion for academic institutions is to implement a fully

integrated clinical trial management system (CTMS).

CTMSs are designed to be customizable enterprise-

wide solution to manage, collect, and analyze data

collected during the entire preclinical and clinical

trial process. The benefits of mapping and develop-

ing an enterprise wide solution include:6

• Centralizing decentralized departments

• Optimizing institutional review board (IRB) func-

tionality

• Realizing real-time data available to both investi-

gators and leadership

• Decreasing bottlenecks in knowledge transfer be-

tween various entities involved in research

• Reducing human errors in reporting that often

cause compliance issues

• Tracking milestones for grants, awards, fellow-

ships, etc.

• Streamlining the financial structure —billing and

invoicing

By implementing a CTMS, AMIs are moving away

from antiquated non-integrated manual processes

and turning to technical solutions to manage the

flow of information associated with conducting clini-

cal trials.

A successful CTMS can provide a well-organized

flow of knowledge throughout the institution and as-

sist senior management in obtaining real-time data

to better analyze the current state of their clinical

research enterprise. Armed with milestone-based,

real-time data, senior management, such as busi-

ness unit directors and department chairpersons, are

better equipped to make strategic decisions to im-

prove overall operational effectiveness, compliance,

governance, and infrastructure (see Figure 1 on page

24). The following list highlights some of the opera-

tional, infrastructure, compliance, and governance

issues that can be improved through the implemen-

tation of a CTMS:

Academic health centers are assessing options to better control the flow of data and boost compliance.



CLINICAL TECHNOLOGY

• Staffing: With a better understanding of resources, manage-

ment will be capable of reallocating staffing assignments to

offset excess or inadequate roles.

• Communication: Improved communication will improve patient

satisfaction and monitoring of clinical trials.

• Human error: CTMSs have integrated checking components to

limit errors in reporting.

• Operational flow: Improved knowledge flow in various divisions

(finance, marketing, administration, training, and recruit-

ment) will help to achieve real-time results and data.

• Managing clinical data: More accurate and efficient reporting

tools will be useful internally and externally for current and

future project assessments.

Choosing a CTMS that serves your institutional needs

There are three general types of CTMS: web-based, cloud-based,

and on-site hosted-based software.7 Each type has distinct

advantages and may have disadvantages depending on the IT

infrastructure at the respective academic medical center. In or-

der to understand your institutional needs, we suggest starting

with defining the purpose or mission of your CTMS. Once the

mission(s) or purpose is defined, then the disparate systems

or system gaps can be assessed and mapped. During the map-

ping exercise, consider exploring the following missions and/or

purposes to build use cases of a well-balanced, operationally

efficient, and compliant CTMS:

• Improvements in clinical, administration, and financial man-

agement of research

• Fostering and improving collaborations among investigators

• Greater understanding of the progress and revenue impact of

clinical trials

• Increasing subject recruitment and safety through the institu-

tion

• Reducing errors and increasing facility compliance

• Operating efficiently and saving research time

Prior to purchasing or implementing a CTMS, it is necessary

to assess the institution’s operational, compliance, and gover-

nance needs and priorities, as well as outline current software

systems (see Table 1 on facing page). Establishing priorities

and identifying current systems can be done in mapping ses-

sions. In these sessions, a cross-functional team of principal

investigators, study coordinators, and senior leadership (such

as the chief information officer, chief financial officer, human

resources representatives, and chief compliance officer) are al-

lowed to identify future system requirements, outline current

software system gaps, and weigh operational, governance, and

compliance priorities. For instance, leadership may insist upon

certain compliance management reporting capabilities, while

investigators may require that the system track pre-award study

start-up milestones, financial reconciliation, and integrate with

electronic health records (EHR). Next, a gap analysis of the re-

search institute’s current software system’s capabilities and the

requirements identified in the mapping sessions versus CTMS-

specific capabilities is completed. The will help to identify the

best CTMS fit for the institution.

After this step, the vendor selection process can begin. Based

on the mapping, most institutions will not be able to pick

a system off the shelf that is fully operational for their clini-

cal research needs. This makes choosing a system somewhat

more complicated than implementing many other types of

institutional systems, such as financial, electronic health man-

agement, and other point of service systems. CTMSs have the

potential to solve many of the compliance, governance, opera-

tional, and managerial issues at academic medical centers with

analytics and reports. So which system do you choose? Unfor-

tunately, for these institutions, currently there are no perfect,

one-size-fits-all CTMSs available in the market. Even though

there is no perfect system, consider reviewing of some common

elements among most of the best systems:

• Financial reporting tools (coverage analysis, residual and

overage reporting)

• Clinical trial management tools (including applicable clinical

trial milestones and reporting dashboards)

• Searchable clinical trial database

• Analytical risk-based decisions

• Reporting dashboards

• Data warehousing module

• Recruitment support module

• Electronic case report form (eCRF)

• Integrates easily with electronic medical records (EMRs), in-

stitutional review board (IRB) system(s), etc.

As the market demand for computerized CTMSs increases, so

does the number of systems solutions. Thus, we may be getting

closer to a system that effectively manages all aspects of the

clinical trial process at academic centers. Until then, any CTMS

implementation will require a certain amount of mapping, cus-

tomization, and implementation support, and may not serve all

analytical and reporting needs.

Source: Stevens et al.

Figure 1. CTMS impact in three key areas.

Potential Benefits

Alignment of CTMS abilities with leadership and

sponsor reporting goals

Information-sharing with other institutions

Healthcare Reform Potential

Data Quality

Data Mining

Data Warehouse

Common systems to increase consistency

across trials

Better reporting and metric-capturing

capabilities

Regulatory compliance/AE and SAE

reporting

Strategic

Operational

effectiveness

Infrastructure



CLINICAL TECHNOLOGY

Cost factors and implementation overview

CTMSs can come with a hefty price tag. In our experience, the

purchase and implementation of a CTMS often means a com-

mitment of two or more years and costs can run into the mil-

lions of dollars. It is essential to take all implementation costs

into consideration before choosing a CTMS. Many systems

offer somewhat low “off the shelf” prices, but these prices don’t

reflect the true cost. It is necessary to consider not only the cost

of the system itself, but the cost of customization, migration of

data from legacy systems (EDC and data warehouses), integra-

tion with other disparate research (IRB, Lawson, EHR) systems,

training, and roll-out timeline when choosing a CTMS. One

other cost consideration is to engage a third party to assist dur-

ing the system selection and implementation phases to provide

program management for such a large investment.

In our experience with the implementation of CTMSs, the fol-

lowing are key aspects of the process:

• Building a steering committee: The most important aspect of im-

plementing a CTMS is having a committee that is capable of

making well-informed decisions for the institution.

• Forecasting future issues: Know the current and future issues of

the institution that hope to be resolved with the CTMS.

• Adapting to change: Understand that implementing a CTMS will

come with new responsibilities. The institution should be

prepared to have individuals fill these new roles. Without this

preparation, the CTMS is doomed from the beginning. New

hires might not be necessary, but rather a shift in responsi-

bilities. Create a culture of transparency to eliminate conflict

and inconsistencies in the future.

• Training and preparation: Design an ongoing tailored training pro-

gram to meet the short- and long-term needs of staff. Imple-

ment training and train staff on the new technology.

• Hiring an external firm: Consider bringing in an

unbiased firm to help people in the institution

understand the true benefits of change. Theå firm

can also provide management with options for

implementation, interface, and utilization.

Conclusion

In today’s clinical research environment, it is no

longer enough to have a disparate stand-alone

system that tracks clinical trials. In reality, a suc-

cessful CTMS solution will require integration

with other systems such as EHR, IRB, and finan-

cials linking all preclinical and clinical research

processes together. This integration creates a

powerful database for clinical trials management,

enabling AMIs access to real-time data and allow-

ing them to maintain and manage various stages

of clinical trials through CTMS data analytics.

Along with strategic, governance, and opera-

tional improvements, a successful CTMS can

improve patient satisfaction, increase return on

investments, enhance communication between departments,

increase the volume of completed trials, and generate an overall

more efficient clinical research portfolio.

References

1. CTSA Home Page, “Clinical & Translational Science Awards Portal.”

https://www.ctsacentral.org/

2. “NIH and the American Recovery & Reinvestment Act (ARRA).” http://

recovery.nih.gov/

3. 3.“Sparking Economic Growth.” The Science Coalition. http://www.

sciencecoalition.org/reports/Sparking%20Economic%20Growth%20

Full%20Report%20FINAL%204-5-10.pdf

4. “Academic-Industry Partnerships for Biopharmaceutical Research.”

http://csdd.tufts.edu/files/uploads/tuftscsdd_academic-industry.pdf

5. “Investing in Clinical Trial Compliance.” Association of Academic

Health Centers. http://www.aahcdc.org/policy/reddot/AAHC_Invest-

ing_in_Clinical_Trial_Compliance.pdf

6. “EDC Focus: “Making The Right Investment In CTMS/EDC.” Contract

Pharma. http://www.contractpharma.com/issues/2009-11/view_fea-

tures/edc-focus-making-the-right-investment-in-ctms-edc/

7. “Clinical Trial Management Systems (CTMS) Market: Global Trends,

Opportunities, Challenge and Forecasts (2011 - 2016).” http://www.

prnewswire.com/news-releases/clinical-trial-management-systems-

ctms-market-global-trends-opportunities-challenge-and-fore-

casts-2011---2016-138385234.html

Erika Stevens is Senior Manager; Christina Eberhart is Manager; and Jim

Moran is Executive Director, all in the Advisory Services practice of Ernst &

Young.

Note: The views expressed are those of the authors and do not necessarily re-

flect the views of Ernst & Young LLP.

System Selection

Internal

socialization and

planning

• Define mission/purpose

• Seek key stakeholder feedback/approval

• Develop an internal/institutional budget, etc.

Requirements

gathering

• Gather user and reporting requirements

(enterprisewide use case(s)

Development of a

request for

proposal (RFP)

• Nominate a Steering Committee

• Develop an RFP based on requirements

• Outline the details of what information is required

and requested relating to implementation timeline

and costs for configuration, integration and inter-

faces

System demos• Perform demos with vendors of select RFP

responses after selection has been narrowed

RFP review and decision

• Steering Committee to review RFPs, participate

in system demos, and select a vendor that most

closely aligns with requirements and price

Source: Stevens et al.

Table 1. Important considerations when choosing a CTMS.

ES542778_ACT1214_025.pgs 12.10.2014 21:05 ADV blackyellowmagenta

Catalent . . . . . . . . . . . . . . . . . 27

CRF Health . . . . . . . . . . . . . . . 28

CROMSOURCE . . . . . . . . . . . . 30

DIA Europe . . . . . . . . . . . . . . . 32

ERT . . . . . . . . . . . . . . . . . . . . 34

Eurofins Central Laboratory . . . 36

Merge eClinical . . . . . . . . . . . . 37

Spectra Clinical Research . . . . 38

FROM THE

STAFF

The staff of Applied Clinical Trials would like extend

our wishes for a new year of happiness and

prosperity to our readers as we enter into 2015.

Our Corporate Profiles section provides readers with the

essential, up-to-date information about the companies that

offer services to the clinical trials community, including

CROs, central laboratories, clinical suppliers, clinical software

developers, and data collection and analysis providers. We

compile this section to give readers the opportunity to gain

a deeper understanding about the products, services, and

capabilities of key vendors in the industry by profiling each

company and highlighting their histories, present, and future.

Please contact the Applied Clinical Trials

staff with your questions and comments.

We look forward to hearing from you.

We hope this resource will be a valuable one.

Best Regards and Cheers,

THE STAFF

Applied Clinical Trials

TABLE OF CONTENTS

DECEMBER 2014 ADVERTISING SECTION OF

CORPORATE PROFILESCROS AND PRODUCT & SERVICE PROVIDERS

RO

BER

T C

HU

RC

HIL

L/G

ETTY IM

AG

ES


December 2014/January 2015 Advertising 27

Corporate Profi les

CATALENT

Corporate Description

Catalyst + Talent. Our name combines these

ideas. From drug and biologic development

services to delivery technologies to supply

solutions, we are the catalyst for your suc-

cess. With more than 80 years of experience

across Rx and consumer markets, we have

the deepest expertise, the broadest offerings,

and the most innovative technologies to help

you get more molecules to market faster,

enhance product performance and provide

superior, reliable manufacturing and packag-

ing results.

Catalent develops. With our broad range

of expert services, we drive faster, more ef-

fcient development timelines to help you take

more molecules to market and create more

effective products.

Catalent delivers. As the world leader in

drug delivery innovations, we have a proven

record of enhancing bioavailability, solubility

and permeability, improving ease and route of

administration, and increasing patient compli-

ance for better treatments.

Catalent supplies. Globally positioned to

serve all your manufacturing and commer-

cial packaging needs, we provide integrated

solutions to take your product from design, to

clinical trial, to plant, and to pharmacy.

Catalent. More products. Better treatments.

Reliably supplied.™

Markets Served

Catalent serves thousands of innovators,

large and small, in over 100 markets. In

Fiscal 2014, Catalent had active business

relationships with 83 of the top 100 pharma-

ceutical marketers, 38 of the top 50 biologics

marketers, and 19 of the top 20 generic drug

marketers.

Catalent Clinical Supply Services has 8

facilities in the US, Europe, and Asia, with

over 50 depots on 6 continents. We provide

about 150,000 clinical trial shipments a year

to more than 80 countries with 99.9% on-time

delivery.

Major Services

Clinical Supply Services: Tailored solutions

from a global leader. With over 25 years of

clinical trial supply experience, serving more

than 4,500 clinical trials, we have the re-

sources and expertise to deliver cost effective

and time sensitive solutions around the world.

Whether you are seeking standalone support

or a comprehensive package, we have the

right solution for you. Our customer-centric

project management and integrated solutions

will help accelerate your project and provide

peace of mind.

Our clinical expertise and offerings span all

facets of clinical trials, including:

• Clinical scale manufacturing

• Direct global comparator sourcing

• Clinical packaging and labeling

• Warehousing, distribution, and returns

management

Development and Analytical Solutions:

Catalent is the world’s number one Formula-

tion and Development partner and leads the

industry with laboratory and chamber capac-

ity, operational excellence, on-time delivery of

reports, and effective regulatory assessment.

Our integrated services provide unique part-

nering effciencies to ensure advancement of

your large or small molecule product through

development and registration to commercial-

ization.

Catalent Pharma Solutions

14 Schoolhouse Road

Somerset, NJ 08873

TELEphoNE

732-537-6200

FAx

732-537-6480

EMAiL

[email protected]

WEBSiTE

www.catalent.com

NuMBEr oF EMpLoyEES

8,000

DATE FouNDED

2007


28 Advertising December 2014/January 2015

Corporate Profi les

CRF Health


CRF Health is a global leader in eCOA

(electronic Clinical Outcome Assessments)

solutions for the life sciences industry.

By improving the process of conducting

clinical studies, we help companies bring

new medicines to market quickly, safely,

and more cost-effectively.

Our powerful TrialMax® software platform

provides a single solution for home or

site-based eCOA collection for Phase I to

IV clinical trials.

Since 2000, our eCOA solutions have been

trusted for 545+ studies and 285,000+

patients in more than 70 countries and in

over 100 languages.

Major Products/Markets Served

Combining the latest technology with

state-of-the-art usability techniques, our

TrialMax® platform supports different

data collection modalities to facilitate the

greatest fexibility in adapting to different

study requirements.

•Simplify data collection – diary guides

patients through the study protocol and

shows the right questionnaires at the right

time.

• Intuitive and easy to use – designed using

graphics and specially designed data entry

felds that everyone can use easily.

•Suitable for different patient populations

– diaries can be specifcally adapted for

the elderly, those with vision and dexterity

problems, or children and teenagers.

•Fits into real lives – reminders mean

patients can get on with life without having

to remember when to answer questions.

Major Services

When it comes to providing electronic clinical

outcome assessment (eCOA) solutions, we not

only give you the tools you need to make your

project a success, we give you full-service

support from start to end. Our support services

include:

• World-class project management

• Collaborative eCOA design

• Data management

• 24/7 helpdesk support

• Global logistics

CRF Health

Corporate Headquarters4000 Chemical Road

Suite 400Plymouth Meeting, PA 19462

+1-267-498-2300

Fredrikinkatu 42FI-00100 Helsinki

Finland+358-201-700-700

Brook House - 3rd Floor 229-243

Shepherds Bush RoadLondon, W6 7AN, UK+44-208-222-7460

E-MAIL

[email protected]

WEBSITE

www.crfhealth.com

NuMBER oF EMPLoyEES

300

DATE FouNDED

2000


Learn more about TrialManager® at CRFHEALTH.COM

IT--IT’S LIKE X-RAY VISION

FOR MY CLINICAL TRIAL!!

see MOREwith TRIALMANAGER

®

TrialManager® offers site, monitor, and study manager dashboards

to highlight actionable alerts, metrics, and trial status.



CROMSOURCE is the leading independent

provider of clinical life science research ser-

vices to the pharmaceutical, biotechnology, and

medical device industries, specialized in clinical

development and staff ng solutions.

A well-established full-service CRO,

CROMSOURCE is unique in offering an End-

to-End Guarantee covering trial timelines,

enrollment, and contract price. This guaran-

tees our clients that their trials are delivered

on time and within the contract price with no

CRO-initiated change orders.

CROMSOURCE operates through off ces

across all regions of Europe and North Amer-

ica and delivers a comprehensive breadth of

services.


CROMSOURCE seamlessly move biophar-

maceutical products from f rst-in-human

conducted in our exceptional early phase unit,

through all subsequent phases of pre- and

post-approval research internationally.

Clinical Development Services

• Feasibility/site selections

• Clinical operations: Project management and

monitoring

• Regulatory affairs

• Regulatory consultancy service

• Medical monitoring

• Medical writing

• Quality assurance

• Pharmacovigilance/materiovigilance

• Data management and statistics

• Drug management

• Vendor management

• Legal representative

• IT: Customized tools & resources

• Staff ng solutions

Early Phase Services

• ADME studies

• Bioavailability

• Bioequivalence

• Dose ranging/multiple dose tolerance

• Drug-drug interactions

• First-in-human (SAD, MAD)

• Food effect studies

• Patient studies

• Pharmacokinetics/pharmacodynamics

• Proof of concept

• QTc studies

Major Services

End-to-End Guarantee. It’s a simple concept,

really. Quality data. On time. On Budget. Guar-

anteed. A unique concept in an environment

where change orders and delays are common-

place with other service providers.

One Trial One Price. The CROMSOURCE

guarantee is our unique pledge that the price

agreed at contract signature is the only price

that the sponsor will pay.

Expert Trial Rescue. CROMSOURCE regularly

rescues projects for clients dissatisf ed with the

progress of ongoing studies. The experienced

CROMSOURCE team quickly assess the situa-

tion and implement tailored solutions which get

such trials back on track.

Feasibility Plus. Feasibility Plus is provided

without obligation at the proposal stage.

Through direct contact with potential investiga-

tors, Feasibility Plus provides accurate country

and site selection data, and allows precise

budget and timeline forecasts.

CROMSOURCE

European Headquarters

Via Giorgio De Sandre, 337135 Verona, Italy

TELEPHONE

+39-045-8222811

FAX

+39-045-8222812

North America Headquarters

One Alewife Center, Suite 120

Cambridge, MA 02140

TELEPHONE

617-871-1128

FAX

617-871-1129

E-MAIL

[email protected]

WEBSITE

www.cromsource.com

NUMBER OF EMPLOYEES

550

DATE FOUNDED

1994

CROMSOURCE

December 2014/January 201530 ADVERTISING

Corporate Profi les


GUARANTEED FIXED PRICE BUDGET

GUARANTEED ENROLMENT & TIMELINES

TIME, COST & QUALITY GUARANTEED

END-TO-END GUARANTEE

North American Headquarters:

Cambridge, MA - USA

Phone +1 617 871 1128

European Headquarters:

Verona - Italy

Phone +39 045 8222811

e-mail us at:

[email protected]


To help professionals keep pace

with the rapidly changing regulatory

environment, the DIA EuroMeeting is

changing too. For 2015, it will share a

venue with the DIA Clinical Forum as

well as the Clinical Forum Exhibition.

This will bring more than 2,500

potential contacts under a single roof.

With three days of opportunities to

learn, connect and build partnerships,

the DIA EuroMeeting is cementing

its place in the product development

calendar.

New challenges,

new opportunities

DIA has always played a vital role in

maintaining the skills and network

of health product development pro-

fessionals. That need is more press-

ing than ever. New understanding of

disease processes, new regulatory

approaches, and the increasing influ-

ence of information technology is ac-

celerating and diversifying healthcare

innovation.

How professionals react to this chal-

lenge will be vital. Embracing this op-

portunity will build upon Europe’s sta-

tus as a hub for healthcare innovation,

stimulating further investment. How-

ever, all stakeholders have a role to

play in creating an environment where

research and regulation are mutually

supportive. This means providing ef-

fective platforms for discussion and

knowledge transfer.

DIA, with more than 18,000 members,

is the perfect organisation to provide

these platforms. It has an enviable

track record in bringing together inno-

vators, regulators and influencers. This

is why the DIA EuroMeeting 2015 is

the ideal opportunity to equip all busi-

nesses with the knowledge and net-

work to prepare for these challenges

future, wherever they sit in the value

chain. The meeting is based around 12

highly topical, relevant themes. Head-

line topics include the new clinical trial

legislation, regulatory coordination

and the impact of big data on health-

care.

Creating a Global

Healthcare Village

However, DIA Meetings ofer more

than listening and learning; they are

a community. The EuroMeeting pro-

vides a unique microcosm of the

health product development environ-

ment; three days of high-quality net-

working and knowledge exchange.

The 2015 EuroMeeting brings further

refinements. By combining the DIA

EuroMeeting and the Clinical Forum

Exhibition into a single site, it will turn

the Palais de Congrès in Paris into a

Global Healthcare Village. With more

than 2,500 stakeholders in one place,

no other conference ofers such a

comprehensive array of stakeholders

and fellow experts spanning the entire

healthcare value chain.

QUICK FACTS

HIGHLIGHTS

- 12 highly relevant, topical

themes

- A microcosm of the health

product development

community

- More than 2,500

stakeholders under one roof

- Relevant throughout the

value chain

CONTACT

www.diahome.org/EM2015

DIA EuroMeeting 2015:

Making the best even betterThe DIA EuroMeeting has always been a significant date in the

agenda of health product development professionals. It is widely

recognised as the leading event for networking and knowledge

transfer thought the development value chain.

Join the conversation: #DIAEuro DIA (DrugInfoAssn)


DIA Europe, Middle East and Africa

Kuechengasse 16

4051 Basel, Switzerland

Healthcare innovation is accelerating and diversifying to meet the

demands posed by societal change. The impact on your business

environment is equally dramatic. The shift to patient-centric business

models is already revolutionising how we do business in Europe

How can you keep your professional knowledge up to speed?

How do you ensure that your network is up to date?

How will you identify and meet the right partners in your

company’s innovation value chain?

12 highly relevant, thought-leading themes

Contacts, networking and solutions - all on a single site

New for 2015: DIA EuroMeeting and the Clinical Forum

Exhibition in a single venue.

More than 2,500 health product development

professionals at a single venue

27th DIA Annual EuroMeeting13-15 April 2015 | Palais des Congrès | Paris

Development, Innovation, Access and Patient Safety

Find the answers to these challenges – and many more - at the

DIA EuroMeeting 2015.

Meet the individuals who can provide the answers to

your challenges: Professionals in the pharmaceutical and

biotech industries, CROs, clinical trial sites, health regulatory

agencies and delegates from academia and patient

organisations and many more.

Visit www.diahome.org/EM2015 for more information

The DIA EuroMeeting 2015 ofers you a microcosm of the evolving European

healthcare landscape, built around three days of high-quality networking,

partnering and knowledge transfer opportunities.


ERT

1818 Market StreetSuite 1000

Philadelphia, PA 19103-3638

TELEPHONE

215-972-0420

FAX

215-972-0414

E-MAIL

[email protected]

WEBSITE

www.ert.com

NUMBER OF EMPLOYEES

857

DATE FOUNDED

1977

Scientif c and Regulatory Consulting

ERT’s consulting group harnesses the industry-

leading expertise of its cardiac safety, respiratory,

and COA scientists to support the clinical devel-

opment needs of biopharmaceutical researchers.

ERT’s consulting group offers reliable services

that support the regulatory approval and com-

mercial optimization for new medical treatments in

development.

Centralized Cardiac Safety

ERT’s Centralized Cardiac Safety solution utilizes

newly developed software technology, within its

best in class EXPERT® operating platform. The

technology enables the collection of real-time,

consistent, and high quality information, eas-

ing site operations and delivering better value to

biopharmaceutical companies. Signif cant cost

savings can be recognized as a result of the

improved data quality and processes associated

with the use of centralized cardiac safety.

Respiratory Solutions

ERT is the industry leader in Centralized Spirom-

etry and Pulmonary Function Testing. From device

customization to clinical data analysis, ERT provides

products and services that ensure the most accurate

data and eff cient trial management in the industry.

ERT’s respiratory services, now fully in the EXPERT®

operating platform, offer quality control, real-time

views of data through a user-friendly web portal, and

Best Test reviews of unacceptable data.

Universal Data Integration, Analytics, and

Visualization

ERT’s innovative cloud-based software plat-

form—eClinical Insights—enables trial sponsors

to integrate data from multiple systems and gain

full visibility across the key aspects of their trials.

This proven, cloud-based software simplif es data

collection, analytics, visibility, and exchange. The

end result is comprehensive insight into investiga-

tive site and outcomes data activity, true risk-based

management, enhanced performance measurement,

and informed real-time decision-making through a

single interface.

For more information about ERT’s leading solutions,

visit: www.ert.com


ERT is a leading provider of high-quality patient

safety and eff cacy endpoint data collection solu-

tions for use in clinical drug development. By inte-

grating innovative solutions built upon a scientif c

and regulatory foundation, ERT collects, analyzes,

and delivers reliable safety and eff cacy data critical

to the approval, labeling, and reimbursement of

pharmaceutical products, while improving clinical

development eff ciency. ERT is the acknowledged

industry leader in:

Multi-Mode eCOA Solutions

When it comes to capturing electronic Clinical

Outcome Assessment (eCOA) data (which includes

PROs, ClinROs, and ObsROs), only ERT offers

all proven modalities: mobile handhelds, tablets,

IVRS, and web. ERT’s technology, scientif c, and

regulatory experts can be relied upon to help

sponsors determine the most effective modality

and approach for collecting eCOA data—whether

through dedicated devices, Bring Your Own Device

(BYOD: available on mobile apps, web, and IVRS)

or a hybrid solution of both approaches. By working

with ERT, sponsors eliminate patient compliance is-

sues, avoid inaccurate, incomplete, or illegible data,

and ultimately produce better-informed data.

Suicide Risk Assessment

ERT’s proven electronic suicide risk assessment

system, AVERT™, enables biopharmaceutical

companies to comply with regulatory requirements

for prospective monitoring of suicidal ideation and

behaviors (SIB) during clinical development. ERT’s

exclusive electronic self-rated version of the Colum-

bia Suicide Severity Rating Scale (eC-SSRS) is a

cost-effective and reliable method of prospectively

monitoring for SIB, and is specif ed as an appropri-

ate means for capturing this important data in the

FDA’s revised Draft Guidance.

ERT

Corporate Profi les

34 ADVERTISING December 2014/January 2015


Eurof ns Central Laboratory

Headquarters:2430 New Holland Pike

Lancaster, PA 17601Tel +1-717-556-7350

Fax +1-717-556-3888

Breda, The Netherlands Tel +31-76-572-7272

Fax +31-76-573-7778

Singapore Tel +65-6562-3858 Fax +65-6562-3086

Shanghai Tel +86-21-6181-7500

Fax +86 21-6181-7501

E-MAIL

clinicaltrials@eurof ns.com

WEBSITE

eurof nscentrallaboratory.com

NUMBER OF EMPLOYEES

250

• Hematology

• Immunochemistry

• Urinalysis

• Coagulation testing

• Flow cytometry

• Biomarkers

• Hormones

• Cell markers

• Cytokine proý ling

• Infectious disease serology

• DNA/RNA isolation and long term storage

• Routine genomic testing

Biomarker Services

• Fit-for-purpose advanced validation and analy-

sis of commercially available biomarker assays

• PK analysis of endogenous compounds (large

molecules)

• Feasibility assessment and scientiý c

consultancy

Global Infectious Disease Services

• Central laboratory microbiology to support

clinical trials

• Clinical virology services

• Scientiý c consultancy

Clinical Trial Supporting Services

• Logistics support and courier management

• Import and export licenses consultancy for

Asia-Paciý c

• Investigator site support

• Multilingual regional helpdesk on three

continents

• Sample management and storage

• Project management

• Data management

IT Systems and EDPs

• Real-time validated global results database via

secured Euroý ns Data Portal (EDP)

• Flagging alerts for out-of-range test results

• Trend analysis tools

• Study-speciý c, customized analysis tools

upon request

Global QC and QA

• Global lot # for controls and calibrators for

global instrument calibration

• External proý ciency testing programs (e.g.,

CAP, EQAS, NEQAS, Randox, NGSP Level 1,

CLIA, ISO 151089, ISO 17025)

• Bi-weekly internal proý ciency testing for all

Euroý ns facilities and standardized partners

About Eurof ns Central Laboratory

Reliable, high-quality laboratory data is pivotal

to the success of clinical trials. Since labora-

tory testing is our sole focus, we go above

and beyond to provide an array of services to

ensure that any clinical trial sample is collected,

transported, managed, analyzed, reported, and

stored to meet the objectives and purpose of

your study. We are dedicated to providing the

most cost-effective and efý cient solutions to

pharmaceutical and biotech companies, and

CROs alike.

Euroý ns Central Laboratory is uniquely

positioned with its Clinical Biomarker Services

by uniting GLP and GCP in one synergetic ap-

proach. This hybrid system allows us to combine

the best of two worlds when utilizing laboratory

biomarkers to prove safety and efý cacy, support

go/no-go decisions, patient stratiý cation, and

submission of data sets to regulatory agen-

cies. Supported by a strong and experienced

Scientiý c Affairs Committee, biomarker assays

are development and validated ý t-for-purpose

to meet the speciý c requirements of the Clinical

Trial Program. Using our scientiý c expertise,

biomarker assay are evaluated for their feasibil-

ity when progressing these assays to a testing

production environment.

Euroý ns Central Laboratory supports its

customers with 5 wholly-owned CAP accredited

laboratory facilities in the United States, Europe,

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Global clinical safety and specialized

testing—Full package of routine and non-routine

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Eurof ns Central

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Corporate Profi les



December 2014/January 2015 ADVERTISING 37

Merge eClinical


Merge eClinical develops and markets smart

software that streamlines the clinical research

process. Our company is built on the belief

that every study—no matter its size, location,

or research setting—deserves the benef ts

offered by information technology to improve

safety, quality, and study outcomes. eClini-

calOS™ (eCOS) is a single, scalable cloud-

based platform that lets clinical research

professionals design, launch, and manage

trials with more control, convenience, and

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The eCOS platform was formally intro-

duced in 2012. Since then it has become

the fastest-growing software platform in the

sector. Merge eClinical is a division of Merge

Healthcare, Inc. (NASDAQ: MRGE), a leading

provider of clinical systems and innovations

that seek to transform healthcare.


With headquarters in Research Triangle

Park, N.C., and off ces around the globe,

Merge eClinical serves researchers in all

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ment needs to our f agship product, eCOS.

With a unique pay-as-you-go model, you

choose only the features you actually need;

eCOS allows you to scale up or down to suit

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With eCOS, you have the freedom to

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Some of the highlights coming in 2015:

Through our “We Support You” program,

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always, expert eCOS-certif ed designers are

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Corporate Profi les


Spectra Clinical Research

8 King RoadRockleigh, NJ 07647

TELEPHONE

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FAX

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E-MAIL

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WEBSITE

www.spectraclinicalresearch.com

biotechnology, research, government, and

academic organizations. We have participated

in trials spanning a wide range of therapeutic

areas including nephrology, gastroenterol-

ogy, oncology, women’s health, and central

nervous system (CNS) disorders. Our global

support network ensures continuous, reliable

service for clinical trials in locations

worldwide including North America, Israel,

South America, Europe, Australia, South

Africa, Asia, and India.

Products and Services

• A dedicated project manager prepares all

study-specif c documents, coordinates

activities with partner laboratories, and at-

tends investigator meetings.

• Specially trained personnel shepherd each

sample through the laboratory.

• Designated customer service representa-

tives assigned to each study ensure

personalized assistance throughout the trial.

• Support for numerous esoteric tests

includes soluble transferrin receptor,

aluminum, zinc, I-PTH, and others.

• Microbiology department offers 24/7

testing services for bacteriology.

• Pediatric testing services.

• ELISA and EIA tests can be set up

and validated.

• Advanced web-based reporting and

data management.


Spectra Clinical Research provides central

laboratory services to pharmaceutical

companies, academic institutions, and other

medical organizations conducting Phase I–IV

clinical trials. Backed by over a decade of

clinical trial expertise and 30 years of central

laboratory services to the dialysis community,

we are able to support diverse clinical trials of

all sizes.

Spectra Clinical Research acts as a unique

resource for organizations conducting clinical

trials. As a division of Spectra Laboratories,

we leverage the capacity and technology of a

large organization while maintaining the

f exibility and responsiveness of a small

specialty laboratory. We continually review

and streamline our processes to ensure

timely, accurate results. Furthermore, our

advanced testing platforms, specimen

management, online data management

application, and dedicated team of service

specialists help move each trial toward a

successful outcome.

Markets Served

Spectra Clinical Research provides

central laboratory services to pharmaceutical,

Spectra Clinical Research

Nicholas Brownlee,PhD, President

We pride ourselves in

working side-by-side with our

customers to understand their

specif c needs and move their

trial toward success.

Corporate Profi les



At Spectra Clinical Research, we believe you deserve more than clinical expertise from your

central laboratory partner. You deserve responsiveness and fexibility. That’s why

our dedicated project managers and customer service specialists make it a point

to understand your unique needs and deliver unmatched support every step of the way.

It’s also why we’re always updating our state-of-the-art facilities and streamlining

our processes to deliver accurate results—on time, every time.

Give us a call today, and see how high we’ll jump for you.

1-800-517-7157 or visit www.spectraclinicalresearch.com

How high?

©2010 Fresenius Medical Care Holdings, Inc. All rights reserved.

www.spectraclinicalresearch.com


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A CLOSING THOUGHT

To see more A Closing Thought articles, visit


Portal innovation is also coming from ven-

dors which offer portal products with a variety

of functionality. Even some contract research

organizations (CROs) have launched portal

products—recognizing the inherent benefits

of reduced study start-up time and more ef-

ficient processes for themselves and their

customers.

The question then becomes, what do the

trial sites want? According to a 2013 site sur-

vey by CenterWatch and Intralinks, 80% of

respondents said they would find value in a

single-login trial web portal that allowed ac-

cess to multiple sponsors. In 2011, a similar

survey conducted by the same parties found

that 73% of sites were still using traditional

communication methods—email, fax, and

courier—as their primary tool for exchanging

clinical trial documents.

With study inefficiencies still present, and

sponsors, vendors, CROs, and sites presum-

ably on board, the industry is still quite early

in the adoption of investigator portals de-

spite the promise they hold. The following are

some of the most impactful benefits inves-

tigator portals can provide to both sponsors

and CROs.

Online Site Profile & Registration

Sites and site staff, through a single sign-

on, enter required information and upload

key documents just one time during study

initiation. This information is then used to

prepopulate documents downstream, and

can be used for future and ongoing studies.

Only a small validation step would be needed

to ensure the information is current. Benefit:

Reduced cycle time during site start up.

Secure Document Exchange with eTMF

Manually tracking the status of required site

documents wastes a considerable amount of

time. It can be days before a CRO or sponsor

realizes a document is missing. Additional

time is then needed to collect the forgotten

document. With a secure document exchange,

sites are proactively notified of missing infor-

mation. This “trigger” can also dramatically

reduce the time needed to get a site qualified

and activated. Benefit: an estimated 20% re-

duction in document collection/maintenance

costs.

In addition, all documents can be stored

and accessed through the electronic trial mas-

ter file (eTMF), as opposed to having hard copy

files at the site. This cloud-enabled “virtual

document binder” would serve as the single

source of site documents, reducing the need

for clinical research associates (CRAs) to rec-

oncile site files to the eTMF during a site visit.

Benefit: an estimated 10% reduction of on-

site CRA time.

Integrated Learning Management System

As the industry becomes more willing to stan-

dardize training across sponsors and CROs,

an integrated learning management system

(LMS) not only reduces the administrative

time needed to track where sites are within

the compliance process, but also in potentially

limiting the need for duplicative site trainings.

Additionally, an integrated LMS could elimi-

nate training duplications from previous stud-

ies by automatically tracking who has received

certain training. Benefit: reduce CRO or spon-

sor efforts and costs of training administra-

tion and compliance by an estimated 25%.

Clinical trial inefficiencies have been well documented and are com-

monly cited as one of the main drivers of the escalating cost of drug

development. So while the discussion around pain points in develop-

ing drugs isn’t new, we are only now starting to see solutions emerge.

The most recent significant development came from the non-profit Trans-

Celerate, which plans to unveil a shared investigator portal accompanied

by an outline for new technology standards that foster interoperability.

Clinical Document Exchange Portals: Trendy or Revolutionary?

While the discussion

around pain points

in developing

pharmaceuticals

isn’t new, we are only

now starting to see

solutions emerge.

Kevin Wojcikewych Senior Director, Business

Optimization, Novella Clinical

E-mail: kwojcikewych@

novellaclinical.com


Barnett’s Self-Instructional Study Site Training SeriesProviding the essential tasks, roles and responsibilities of the clinical study team, this

6-volume series covers study site requirements through self-paced learning activities.

State-by-State Clinical Trials Requirements Reference GuideCovering clinical trial standards in all 50 US states, this resource breaks

down each state’s requirements in more than a dozen practical areas.

Order your copies today. Visit our website at

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Good Clinical Practice: A Question & Answer Reference GuideThis industry-leading guide answers over 1,200 of the most common and difficult questions

regarding the interpretation and implementation of US and International GCP standards.

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the basics of CRA requirements in today’s environment.

CFR/ICH GCP Reference Guide

CFR/ICH GCP Reference Guide for Medical Devices

Glossary & Acronyms for Clinical Research Professionals

HIPAA & US Clinical TrialsDesigned for organizations that sponsor, conduct or oversee clinical trials in the US that

depend on usage and disclosure of research subjects’ health information.


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